510(k) K083002

SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER by Sysmex America, Inc. — Product Code LKM

K083002 is an FDA 510(k) premarket notification submitted by Sysmex America, Inc. for the device "SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER". The FDA issued a decision of Substantially Equivalent on February 3, 2009. The device falls under product code LKM (Counter, Urine Particle), a Class II device regulated under 21 CFR 864.5200. Sysmex America, Inc. has at least 10 other 510(k) clearances on record.